Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091325
Status:
COMPLETED
Last Update Posted:
2010-01-20
First Post:
2004-09-07
Brief Title:
Green Tea Extract Polyphenon E in Preventing Cancer in Healthy Participants
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Phase I Drug Interaction Clinical Study of Polyphenon E
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Green tea extract Polyphenon E contains ingredients that may prevent the development of cancer
PURPOSE This phase I trial is studying how well green tea extract works in preventing cancer in healthy participants
PURPOSE This phase I trial is studying how well green tea extract works in preventing cancer in healthy participants
Detailed Description:
OBJECTIVES
Primary
Determine the effect of green tea extract Polyphenon E on cytochrome P450 enzyme activities and glutathione S-transferase activities and levels in healthy participants
Secondary
Determine the safety and tolerability of this drug in these participants
OUTLINE This is an open-label study
Participants receive oral green tea extract Polyphenon E once daily for 4 weeks in the absence of unacceptable toxicity
Participants are followed for 2 weeks
PROJECTED ACCRUAL A total of 44 participants will be accrued for this study
Primary
Determine the effect of green tea extract Polyphenon E on cytochrome P450 enzyme activities and glutathione S-transferase activities and levels in healthy participants
Secondary
Determine the safety and tolerability of this drug in these participants
OUTLINE This is an open-label study
Participants receive oral green tea extract Polyphenon E once daily for 4 weeks in the absence of unacceptable toxicity
Participants are followed for 2 weeks
PROJECTED ACCRUAL A total of 44 participants will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UARIZ-HSC-0499 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA023074 |
| P30CA023074 | NIH | None | None |